A Study to Evaluate Immunogenicity and Safety of Boostrix Compared to Adacel When Administered as a Booster Vaccination in Adults Aged 19 to 64 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,337
- 试验地点
- 43
- 主要终点
- Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
研究概览
简要总结
GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study.
- •Chronic administration of immunosuppressants or within six months prior to administration of study vaccine.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine).
- •Administration of a diphtheria-tetanus (Td) booster within previous five years.
- •Administration of Tdap vaccine at any time prior to study entry. History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.
研究组 & 干预措施
Boostrix Group
Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
干预措施: Boostrix™ (Biological)
Adacel Group
Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
干预措施: ADACEL® (Biological)
结局指标
主要结局
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
时间窗: At Month 1
Concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
时间窗: At Month 1
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 0.1 international units per milliliter (IU/mL).
Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies
时间窗: At Month 1
A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
时间窗: At Month 1
Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (\<) 5 EU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (≥) 20 EU/mL), one month after vaccination; for initially seropositive subjects with pre-vaccination concentration ≥ 5 EU/mL and \< 20 EU/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EU/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration, one month after vaccination.
次要结局
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 15-day period (Day 0-14) following vaccination)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the 31-day period (Days 0-30) following vaccination)
- Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies(At Month 1)
- Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)(At Month 1)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 15-day period (Day 0-14) following vaccination)
- Number of Subjects Reporting Hospitalizations(During the extended safety follow-up (ESFU) period (from Day 31 to Month 6))
- Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations(At Month 1)
- Number of Subjects Reporting Emergency Room Visits(During the extended safety follow-up (ESFU) period (from Day 31 to Month 6))
- Number of Subjects With Serious Adverse Events (SAEs)(During the extended safety follow-up (ESFU) phase (Day 31 - Month 6))
- Number of Subjects Reporting the Onset of New Chronic Illnesses(During the extended safety follow-up (ESFU) period (from Day 31 to Month 6))
- Number of Subjects With Serious Adverse Events (SAEs).(During the active phase of the study (Day 0 - Day 30))